Global Quality Systems Director for MedTech

BD; Wyckoff (NJ); On-site; USD 212,000 - 339,000; Full time

Job summary

BD is seeking a seasoned QA leader to drive the Specimen Management Quality Systems (SM QMS) and ensure alignment with MDR/IVDR and other global regulations. You will lead development, implementation, and continuous improvement of QMS processes, acting as the primary liaison for audits and regulators while coaching future quality leaders across a global network.

The role focuses on building a robust, compliant, and efficient QMS that supports BD’s mission to advance health, with frequent

Qualifications

• Minimum 10 years of QA leadership experience in a regulated environment.
• Expert knowledge of FDA QSR, ISO 13485, EU MDR/IVDR requirements.
• Experience implementing and maintaining QMS across multiple sites.

Responsibilities

• Lead Specimen Management Quality Systems (SM QMS) strategy across locations.
• Design, develop and implement QMS processes aligned with corporate goals.
• Serve as point person for internal and external audits and regulatory inspections.
• Coordinate SM communications with regulators to build consistency and trust.
• Develop long-term SM QMS strategy and build future quality leaders.

Skills

Quality leadership

Regulatory knowledge

Audits

QMS development

Cross-functional leadership

CAPA

Document control

Education

BS degree in technical field

Job description

BD is seeking a seasoned QA leader to drive the Specimen Management Quality Systems (SM QMS) and ensure alignment with MDR/IVDR and other global regulations. You will lead development, implementation, and continuous improvement of QMS processes, acting as the primary liaison for audits and regulators while coaching future quality leaders across a global network.

The role focuses on building a robust, compliant, and efficient QMS that supports BD’s mission to advance health, with frequent